This application claims priority from U.S. Patent application Ser. No. 61/305,885, filed Feb. 18, 2010. and entitled “Infusion Sleeve with Leakage Control”, which is incorporated herein in its entirety by reference.
This invention relates to surgical instruments and surgical techniques used in eye surgery and more particularly, to the technique of phacoemulsification apparatus and methods for their use.
A common ophthalmological surgical technique is the removal of a diseased or injured lens from the eye. Earlier techniques used for the removal of the lens typically required a substantial incision to be made in the capsular bag in which the lens is encased. Such incisions were often on the order of 12 mm in length.
Later techniques focused on removing diseased lenses and inserting replacement artificial lenses through as small an incision as possible. For example, it is now a common technique to take an artificial intraocular lens (IOL), fold it and insert the folded lens through the incision, allowing the lens to unfold when it is properly positioned within the capsular bag. Similarly, efforts have been made to accomplish the removal of the diseased lens through an equally small incision.
One such technique is known as phacoemulsification. A typical phacoemulsification tool includes a hollow needle to which electrical energy is applied to vibrate the needle at ultrasonic frequencies in order to fragment the diseased lens into small enough particles to be aspirated from the eye. Commonly, an infusion sleeve is mounted around the needle to supply irrigating liquids to the eye in order to aid in flushing and aspirating the lens particles.
It is extremely important to properly infuse liquid during such surgery. Maintaining a sufficient amount of liquid prevents collapse of certain tissues within the eye and attendant injury or damage to delicate eye structures. As an example, endothelial cells can easily be damaged during such collapse and this damage is permanent because these cells do not regenerate. One of the benefits of using as small in incision as possible during such surgery is the minimization of leakage of liquid during and after surgery and the prevention of such a collapse
During phacoemulsification any aspiration liquid directed by the sleeve in a forward direction tends to repulse emulsified lens particles. Repulsion makes the phacoemulsification process less efficient and requires the surgeon to move the needle to bring the aspiration port on the needle close enough to the particles to aspirate them.
There are known prior art designs of sleeves with ports that are arranged to deliver irrigating liquid in a direction other than straight forward. However, a source of forward flow is the leakage of irrigating liquid through the forward portion of the sleeve between the sleeve and the outer needle surface.
Instruments using various types of infusing sleeves are well known and well-represented in the art and exemplify the attempts made by others to address the problem of maintaining an adequate flow of irrigating liquid without causing damage to the eye.
U.S. Pat. No. 4,643,717 (Cook et al) teaches and describes an aspiration fitting adapter formed as a sleeve concentric to the phaco needle and having a pair of bilaterally opposed discharge ports formed proximate the end of the sleeve to infuse irrigating liquid into the eye.
U.S. Pat. No. 5,151,084 (Khek) teaches and describes an ultrasonic needle with an infusion sleeve that includes a baffle. The sleeve of Khek also fits concentrically about the needle and allows the needle to protrude a substantial distance therefrom while providing pair of discharge ports bilaterally opposed to each other near the terminus of the sleeve.
U.S. Pat. No. 6,117,151 (Urich et al) teaches and describes an eye incision temperature protection sleeve fitted concentrically about a needle and having a single discharge port through which irrigating liquid is passed.
U.S. Pat. No. 6,605,054 (Rockley) teaches and describes a multiple bypass port phaco tip having multiple aspiration ports and a single discharge port to infuse liquid into the eye.
U.S. Pat. No. 5,879,356 (Geuder) teaches and describes a surgical instrument for crushing crystalline eye lenses by means of ultrasound and for removing lens debris by suction which demonstrates the use of a sleeve positioned concentric to the needle and having a pair of discharge ports formed thereon.
A series of patents issued to Richard J. Mackool illustrates further variations of irrigating sleeves. Mackool forms the sleeve with a somewhat flattened cross-section configuration intended to more closely approximate the shape of the incision through which the sleeve is inserted into the eye. This cross-section can be seen at FIG. 3 of U.S. Pat. No. 5,084,009.
U.S. Pat. No. 5,084,009 (Mackool) teaches and describes a liquid infusion sleeve for use during eye surgery with the sleeve having a flattened cross-section and having a pair of infusion ports formed on the forward portion of the flattened section.
U.S. Pat. No. 5,286,256 (Mackool) teaches and describes a liquid infusion sleeve having a free-floating rigid sleeve surrounding a needle which is intended to prevent the outer flexible sleeve from collapsing onto the needle.
U.S. Pat. No. 5,354,265 (Mackool) teaches and describes a liquid infusion sleeve showing yet another construction intended to keep the outer flexible infusion sleeve from collapsing onto the vibrating needle.
U.S. Pat. No. 5,505,693 (Mackool) teaches and describes a method and apparatus for reducing friction and heat generation by an ultrasonic device during surgery incorporating a needle support to prevent collapse of the outer flexible sleeve.
The Mackool patents are characterized by a pair of discharge ports formed at the distal end of the sleeve through which irrigating liquid is passed into the eye during the operation.
U.S. Pat. No. 5,645,530 (Boukhny) teaches and describes a phaco emulsification sleeve, one variation of which has a bellows portion attached to a discharge port ring which directs an annular flow of liquid around the needle and into the eye. The use of the bellows is intended to allow the sleeve to absorb spikes in liquid pressure during the operation.
U.S. Pat. No. 5,634,912 (Injev) teaches and describes an infusion sleeve having a rotating tip to allow the phaco needle to be repositioned during surgery. The top also has a single discharge port for infusing liquid during surgery.
Published U.S. Patent Application No. 2003/0004455 (Kadziauskas) teaches and describes a bi-manual phaco needle using separate emulsification and aspiration needles inserted into the eye simultaneously during surgery.
While the foregoing references describe the problems faced during phacoemulsification with respect to supplying the eye with an adequate amount of irrigating liquid, they do not particularly point out nor describe apparatus nor methods for limiting the forward leakage of irrigating liquid during phacoemulsification.
Accordingly, a need exists for an improved infusion sleeve which allows for an adequate volume of liquid to be infused into the eye while limiting the forward leakage of said liquid. This is particularly important with sleeves allowing for increased flow of liquid which, in turn, places greater stress on the sleeve.
The need also exists for such improved infusion sleeves to be simple in construction, efficient in operation and economical to manufacture.
In accordance with the preferred embodiment of the present invention, a phacoemulsification infusion sleeve has a thickened forward portion providing an enhanced barrier to forward leakage.
In another embodiment of the present invention, a ridge is formed on the internal surface of the forward portion of the phacoemulsification sleeve and a corresponding groove is formed on the exterior surface of the phacoemulsification needle. When the sleeve is applied to the needle, the ridge is seated in the groove.
In accordance with another preferred embodiment of the present invention, a ridge is formed on the external surface of the needle and a corresponding groove is formed on the internal surface of the sleeve. When the sleeve is applied to the needle, the ridge and groove seat to form a seal.
In accordance with another preferred embodiment, an O-ring or O-ring type insert is formed proximate the end of the sleeve and contacts the exterior surface of the needle when the sleeve is applied to the needle.
While the following describes a preferred embodiment or embodiments of the present invention, it is to be understood that this description is made by way of example only and is not intended to limit the scope of the present invention. It is expected that alterations and further modifications, as well as other and further applications of the principles of the present invention will occur to others skilled in the art to which the invention relates and, while differing from the foregoing, remain within the spirit and scope of the invention as herein described and claimed. Where means-plus-function clauses are used in the claims such language is intended to cover the structures described herein as performing the recited functions and not only structural equivalents but equivalent structures as well. For the purposes of the present disclosure, two structures that perform the same function within an environment described above may be equivalent structures.
These and further aspects of the present invention will become apparent upon consideration of the accompanying drawing figures in which: